Safety and Effectiveness Study of the Precision SCS Systems Adapted for High-Rate Spinal Cord Stimulation (ACCELERATE)

Boston Scientific

Status

Completed

Conditions

Back Pain

Chronic Pain

Treatments

Device: PRECISION SCS Adapted for High-Rate SCS

Study type

Interventional

Funder types

Industry

Identifiers

NCT02093793

A4007

Details and patient eligibility

About

To evaluate the safety and effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation as an aid in the management of chronic intractable pain

Full description

To evaluate the safety and effectiveness of high rate spinal cord stimulation (HR-SCS) therapy as an aid in the management of chronic intractable pain of the trunk using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation

Enrollment

383 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have been diagnosed with chronic, intractable pain of the trunk (NRS ≥ 5) which has been refractory to conservative therapy for a minimum of 90 days.
Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
Be 22 years of age or older at the time of enrollment
Be willing and capable of giving informed consent
Be willing and able to comply with study-related requirements, procedures, and visits

Exclusion criteria

Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist
Have previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
Have a current systemic infection, or local infection in close proximity to anticipated surgical field
Pregnant or plan to get pregnant during the course of the study or not using adequate contraception.
Be participating in another clinical study that may influence the data collected for the study